Conference Day Two
8:00 am Check In & Coffee
8:40 am Chair’s Opening Remarks
Advancing Collaboration Between Engineers & Regulators
8:45 am Panel Discussion: Aligning Engineers & Regulators for Seamless Collaboration
Synopsis
- Tackling communication barriers in highly regulated environments and creating a shared language between engineering and regulatory teams
- Overcoming common misalignments in goals and timelines, with practical strategies to enhance collaboration without compromising technical and regulatory integrity
- Real-world case studies on how leading companies have successfully aligned engineering and regulatory teams to achieve faster approvals and innovation
9:15 am Collaborative Risk Assessment for Faster Approvals
Synopsis
- Ensuring a streamlined risk assessment process that involves both engineering and regulatory teams
- Revealing how to conduct joint risk assessments that satisfy both compliance and development needs without delays
- Outlining techniques for maintaining regulatory timelines while addressing engineering challenges
9:45 am Key Considerations for Sponsors & Manufacturers of SaMDs & Medical Devices in Clinical Trials
Synopsis
- Understanding risk management requirements, regulatory frameworks, and compliance standards such as ISO 14155 and ISO 13485
- Aligning software development, clinical validation, and regulatory compliance to streamline approval and trial success
- Implementing fit-for-purpose strategies to balance patient safety, data collection, and usability in clinical study protocols
10:15 am Harmonizing Quality Management with Regulatory Expectations: Bridging the Gap
Synopsis
- Aligning quality systems with regulatory standards by ensuring quality management systems (QMS) are designed to meet both regulatory and internal quality expectations
- Managing software and hardware integration by integrating regulatory compliance into hybrid systems where software and hardware components interact seamlessly in medical devices
- Optimizing Post-Market Surveillance and Compliance through strategies that harmonize regulatory expectations with post market activities, ensuring ongoing compliance and quality management
10:45 am Morning Break & Networking
From Concept to Clinical Impact: Building Smarter Medical Devices
11:30 am Leveraging Open-Source Tools for Medical Device Software Development
Synopsis
- Improving speed and flexibility by utilizing open-source tools to streamline development and enable faster iterations
- Ensuring regulatory compliance by integrating open-source solutions that meet industry standards
- Building collaborative ecosystems by tapping into open-source communities for innovation and shared expertise while managing risks
12:00 pm Efficient Iterations: Reducing Time-to-Market for Medical Devices
Synopsis
- Implementing agile methodologies to shorten development cycles and speed up time-to market
- Integrating agile processes with regulatory requirements to avoid bottlenecks in approval timelines
- Highlighting how iterative testing and validation have expedited product launches without compromising safety or compliance
- Real-world examples: Fibresolve (de novo) and ScreenDx (510k)
Driving Better Patient Outcomes Through Smarter, AI-Enabled Technologies
12:30 pm Roundtable: The Role of Edge Computing in Real-Time Healthcare: Opportunities & Challenges
Synopsis
- How can AI integration on the edge enhance real-time decision-making for clinicians and improve patient outcomes?
- What are the key technical and regulatory challenges when integrating edge computing in medical devices, and how can they be addressed to ensure compliance and functionality?
- How should the healthcare industry approach the ethical implications of real-time AI decision-making in medical devices?
1:00 pm Lunch & Networking
2:00 pm Transforming Patient Care with Predictive Algorithms & Real-Time Physiological Data
Synopsis
- Adding value by developing predictive algorithms for real-time detection of patient deterioration before clinical recognition
- Avoiding bias through the harnessing of continuous physiological data to create unbiased, data-driven solutions
- Overcoming the last mile by focusing on deployment and clinical integration
2:30 pm HeartSciences Pillars of Excellence: A Story About how we Built a Medical Device Data System (MDDS) & Class II Cardiovascular Machine Learning- Based Notification Software in Record Time
Synopsis
- Collaborating regularly with clinicians to validate designs, gather feedback, and align solutions with real-world clinical needs
- Integrating AI seamlessly into clinical workflows while addressing data access challenges and regulatory requirements
- Leveraging agile development and strategic partnerships to enhance cybersecurity, streamline processes, and accelerate high-quality product delivery
2:30 pm Roundtable: Shaping the Future of Medical Devices: Innovation, Compliance, and Patient-Centric Development
Synopsis
- How can the industry balance the rapid pace of technological innovation with the need to comply with increasingly complex regulatory frameworks?
- What are the most effective strategies for addressing challenges in post-market surveillance and ensuring continuous compliance with evolving regulations?
- How can we ensure that patient needs and real-world outcomes are prioritized throughout the entire product lifecycle, from design to market entry and beyond?
3:00 pm Data-Driven Innovation: Leveraging Big Data & AI in Development & Validation
Synopsis
- Building a data-driven ecosystem to enhance software validation, optimize testing processes, and accelerate iterative development
- Exploring how big data and AI-driven analytics can identify software flaws, improve accuracy, and optimize device functionality
- Navigating the regulatory landscape for integrating AI into software development while ensuring compliance with medical device standards